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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02065700
Registration number
NCT02065700
Ethics application status
Date submitted
14/02/2014
Date registered
19/02/2014
Date last updated
4/06/2024
Titles & IDs
Public title
Long-term Follow-up Study of GLPG0634 in Active Rheumatoid Arthritis Participants
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Scientific title
A Multicenter, Open-label, Long-term Follow-up Safety and Efficacy Study of GLPG0634 Treatment in Subjects With Moderately to Severely Active Rheumatoid Arthritis
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Secondary ID [1]
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2012-003655-11
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Secondary ID [2]
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GLPG0634-CL-205
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Universal Trial Number (UTN)
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Trial acronym
DARWIN3
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis
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Condition category
Condition code
Musculoskeletal
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Osteoarthritis
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Inflammatory and Immune System
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Rheumatoid arthritis
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Filgotinib
Experimental: Filgotinib Darwin 1 - Participants in Study GLPG0634-CL-203 (NCT01888874) were rolled-over to receive an oral dose of filgotinib at a daily dose of 200 milligrams (mg) in this extension study, with the exception of male participants in the United States (US) who were limited to a daily dose of 100 mg due to a Food and Drug Administration (FDA) requirement based on a non-clinical finding. Treatment was administered until marketing, local (if applicable) regulatory and/or pertinent local reimbursement approval.
In case of intolerance or for safety reasons, and as per investigator's discretion, a daily dose of filgotinib 200 mg could be decreased to 100 mg per day, and later returned to 200 mg per day after the reasons for decreasing the dose were resolved.
Experimental: Filgotinib Darwin 2 - Participants from Study GLPG0634-CL-204 (NCT01894516) were rolled-over to receive oral dose of filgotinib tablet at 200 mg once daily (q.d) in this extension study. Treatment was administered until marketing, local (if applicable) regulatory and/or pertinent local reimbursement approval.
Participants started the study with the same dose level (filgotinib 200 mg per day) and in case of intolerance or safety reasons and as per investigator's discretion, the daily dose of filgotinib was decreased to 100 mg q.d and was returned to 200 mg per day after the reasons for decreasing the dose had resolved and at the investigator's discretion.
Treatment: Drugs: Filgotinib
Administered as Oral Tablets
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants Experiencing Treatment-Emergent Adverse Events
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Assessment method [1]
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An Adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product.
Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the filgotinib start date in the core studies or GLPG0634-CL-205 (NCT02065700), and no later than 30 days after permanent discontinuation of filgotinib in GLPG0634-CL-205 (NCT02065700) or of either 30 days after the last dose date.
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Timepoint [1]
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From First dose to Week 437
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Secondary outcome [1]
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Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI)
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Assessment method [1]
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The American College of Rheumatology (ACR) response was a measurement of improvement in multiple disease assessment criteria.
The ACR20 response was defined as: 1) = 20% improvement from baseline in swollen joint count 66 (SJC66), and 2) = 20% improvement from baseline in tender joint count 68 (TJC68), and 3) = 20% improvement from baseline in at least 3 of the following 5 items: 1. Pain visual analog scale (VAS) (taken from the Health Assessment Questionnaire - Disability Index [HAQ-DI]), 2.Subject's Global Assessment of Disease Activity (SGA) (VAS), 3. Physician's Global Assessment of Disease Activity (PGA) (VAS), 4. Total HAQ-DI score, and 5. High-Sensitivity C- Reactive Protein (hsCRP).
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Timepoint [1]
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Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408
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Secondary outcome [2]
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Percentage of Participants Achieving ACR20 Response: Observed Case (OC)
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Assessment method [2]
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The ACR response was a measurement of improvement in multiple disease assessment criteria.
The ACR20 response was defined as: 1) = 20% improvement from baseline in SJC66, and 2) = 20% improvement from baseline in tender TJC68, and 3) = 20% improvement from baseline in at least 3 of the following 5 items: 1. Pain VAS (taken from the HAQ-DI), 2.SGA (VAS), 3. PGA (VAS), 4. Total HAQ-DI score, and 5. hsCRP.
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Timepoint [2]
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Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408
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Secondary outcome [3]
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Percentage of Participants Achieving ACR50 Response: NRI
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Assessment method [3]
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The ACR response was a measurement of improvement in multiple disease assessment criteria.
ACR50 response was defined as: 1) = 50% improvement from baseline in SJC66, and 2) = 50% improvement from baseline in TJC68, and 3) = 50% improvement from baseline in at least 3 of the following 5 items: 1. Pain VAS (taken from the HAQ-DI) 2.SGA (VAS) 3. PGA (VAS) 4. Total HAQ-DI score 5. hsCRP.
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Timepoint [3]
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Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408
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Secondary outcome [4]
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Percentage of Participants Achieving ACR50 Response: OC
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Assessment method [4]
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The ACR response was a measurement of improvement in multiple disease assessment criteria.
ACR50 response was defined as: 1) = 50% improvement from baseline in SJC66, and 2) = 50% improvement from baseline in TJC68, and 3) = 50% improvement from baseline in at least 3 of the following 5 items: 1. Pain VAS (taken from the HAQ-DI) 2.SGA (VAS) 3. PGA (VAS) 4. Total HAQ-DI score 5. hsCRP.
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Timepoint [4]
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Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408
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Secondary outcome [5]
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Percentage of Participants Achieving ACR70 Response: NRI
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Assessment method [5]
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The ACR response was a measurement of improvement in multiple disease assessment criteria.
ACR70 response was defined as : 1) = 70% improvement from baseline in SJC66, and 2) = 70% improvement from baseline in TJC68, and 3) = 70% improvement from baseline in at least 3 of the following 5 items: 1. Pain VAS (taken from the HAQ-DI), 2.SGA (VAS), 3. PGA (VAS), 4. Total HAQ-DI score, and 5. hsCRP.
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Timepoint [5]
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Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408
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Secondary outcome [6]
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Percentage of Participants Achieving ACR70 Response: OC
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Assessment method [6]
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The ACR response was a measurement of improvement in multiple disease assessment criteria.
ACR70 response was defined as : 1) = 70% improvement from baseline in SJC66, and 2) = 70% improvement from baseline in TJC68, and 3) = 70% improvement from baseline in at least 3 of the following 5 items: 1. Pain VAS (taken from the HAQ-DI), 2.SGA (VAS), 3. PGA (VAS), 4. Total HAQ-DI score, and 5.hsCRP.
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Timepoint [6]
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Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408
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Secondary outcome [7]
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ACR N% Improvement (ACR-N) Response: OC
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Assessment method [7]
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ACR-N was defined as the smallest percentage improvement from core baseline in SJC66, TJC68 and the median of the following 5 items (Pain VAS [taken from the HAQ-DI], 2.SGA (VAS), 3. PGA (VAS), 4. Total HAQ-DI score, and 5. hsCRP). It had a range between 0 and 100%.
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Timepoint [7]
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Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408
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Secondary outcome [8]
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Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC
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Assessment method [8]
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The DAS28(CRP) was a measure of the participant's disease activity calculated using the TJC (28 joints), SJC (28 joints), SGA [using a VAS on a scale of 0 (very well) to 100 (very poor)] and hsCRP using the formula:
DAS28(CRP) = 0.56 * Square root [SQRT] (TJC28) + 0.28 * SQRT(SJC28) + 0.36 * Ln(CRP+1) + 0.014 * SGA + 0.96
and the total possible score ranged from 1 to 9.4. Higher values indicated higher disease activity. A negative change from baseline indicated improvement.
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Timepoint [8]
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Core Baseline, Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408
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Secondary outcome [9]
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Change From Core Baseline in Simple Disease Activity Index (SDAI): OC
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Assessment method [9]
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SDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA (0 to 10 cm), PGA (0 to 10 cm), CRP (mg/dL). SDAI = TJC + SJC + SGA + PGA+ CRP. The SDAI score ranged from 0 to approximately 86. Higher SDAI indicated greater disease activity. A negative change from baseline indicated improvement.
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Timepoint [9]
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Core Baseline, Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408
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Secondary outcome [10]
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Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC
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Assessment method [10]
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The CDAI was the SDAI modified that excluded CRP and consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA (0 to 10 cm), PGA (0 to 10 cm). SDAI = TJC + SJC + SGA+ PGA. The CDAI score ranged from 0 to approximately 76. Higher CDAI indicated greater disease activity. A negative change from baseline indicated improvement.
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Timepoint [10]
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Core Baseline, Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408
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Secondary outcome [11]
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Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
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Assessment method [11]
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DAS28(CRP) was categorized into EULAR response categories (none, moderate, good) as follows:
None= Actual DAS28(CRP) = 3.2, > 3.2 to = 5.1, or > 5.1 AND Improvement in DAS28(CRP) from baseline = 6.0 or > 0.6 to = 1.2;
Moderate= Actual DAS28(CRP) = 3.2 AND Improvement in DAS28(CRP) from baseline > 0.6 to = 1.2, Actual DAS28(CRP) > 3.2 to = 5.1 or > 5.1 AND Improvement in DAS28(CRP) from baseline > 1.2, or Actual DAS28(CRP) > 3.2 to = 5.1 AND Improvement in DAS28(CRP) from baseline > 0.6 to = 1.2;
Good= Actual DAS28(CRP) = 3.2 AND Improvement in DAS28(CRP) from baseline > 1.2.
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Timepoint [11]
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Core Baseline, Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408
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Secondary outcome [12]
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Percentage of Participants Achieving ACR/EULAR Remission: NRI
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Assessment method [12]
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A participant's disease activity status was defined as being in remission when scores on the TJC28, SJC28, CRP (actual value in mg/dL) and SGA (cm) were all = 1.
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Timepoint [12]
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Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408
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Secondary outcome [13]
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Percentage of Participants Achieving ACR/EULAR Remission: OC
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Assessment method [13]
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A participant's disease activity status was defined as being in remission when scores on the TJC28, SJC28, CRP (actual value in mg/dL) and SGA (cm) were all = 1.
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Timepoint [13]
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Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408
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Secondary outcome [14]
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Change From Core Baseline in Physical Component Score (PCS) of Quality of Life Using the Short Form-36 (SF-36) Scores: OC
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Assessment method [14]
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The health-related quality of life of the subject was assessed using the SF-36 with a 4-week recall period. This consists of 36 questions belonging to 8 domains in 2 components:
Physical well-being: 4 domains: physical functioning (10 items), role physical (4 items), bodily pain (2 items), and general health (GH) perceptions (5 items).
Mental well-being: 4 domains: vitality (4 items), social functioning (2 items), role emotional (3 items), and mental health (5 items).
These scales were from 0 to 100 with higher scores indicating a better quality of life.
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Timepoint [14]
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Core Baseline, Extension Baseline, Weeks 48, 96, 144, 192, 240, 288, 336, 384
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Secondary outcome [15]
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Change From Core Baseline in MCS of Quality of Life Using the SF-36 Scores: OC
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Assessment method [15]
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The health-related quality of life of the subject was assessed using the SF-36 with a 4-week recall period. This consists of 36 questions belonging to 8 domains in 2 components:
Physical well-being: 4 domains: physical functioning (10 items), role physical (4 items), bodily pain (2 items), and general health (GH) perceptions (5 items).
Mental well-being: 4 domains: vitality (4 items), social functioning (2 items), role emotional (3 items), and mental health (5 items).
These scales were from 0 to 100 with higher scores indicating a better quality of life.
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Timepoint [15]
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Core Baseline, Extension Baseline, Weeks 48, 96, 144, 192, 240, 288, 336, 384
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Secondary outcome [16]
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Change From Core Baseline in Quality of Life Using Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale: OC
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Assessment method [16]
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FACIT-Fatigue scale was a 13-item questionnaire, each scored on a 5-point scale: 0 (Not at all) to 4 (Very much). Negatively stated items were reversed by subtracting the response from "4" before being added to obtain a total score. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score), with a higher score indicating less fatigue. A positive change from baseline indicated better quality of life.
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Timepoint [16]
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Core Baseline, Extension Baseline, Weeks 48, 96, 144, 192, 240, 288, 336, 384
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Eligibility
Key inclusion criteria
Key
- Participants who completed one of the qualifying core studies GLPG0634-CL-203 or
GLPG0634-CL-204 and may benefit from filgotinib long-term treatment according to the
Investigator's judgment
- Females of childbearing potential and sexually active men must agree to use highly
effective method of birth control as specified in the protocol, during the study and
for at least 12 weeks after the last dose of filgotinib
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Participants who prematurely withdrew from one of the 2 core studies (GLPG0634-CL-203
or GLPG0634-CL-204), for any reason
- Persistent abnormal lab values during one of the 2 core studies (GLPG0634-CL-203 or
GLPG0634-CL-204), according to the Investigator's judgment
- Diagnosis of rheumatic autoimmune disease or inflammatory joint disease other than
rheumatoid arthritis, except for secondary Sjogren's syndrome
- Any condition or circumstances which, in the opinion of the Investigator, may make a
participant unlikely or unable to complete the study or comply with study procedures
and requirements
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
25/02/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
19/01/2023
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Sample size
Target
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Accrual to date
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Final
739
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Recruitment in Australia
Recruitment state(s)
Flinders Drive, SA,VIC
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Recruitment hospital [1]
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Flinders Medical Centre - Bedford Park
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Recruitment hospital [2]
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Monash Medical Centre - Clayton
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Recruitment hospital [3]
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Princess Alexandra Hospital - Woolloongabba
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Recruitment postcode(s) [1]
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- Bedford Park
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Recruitment postcode(s) [2]
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- Clayton
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Recruitment postcode(s) [3]
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- Woolloongabba
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arizona
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United States of America
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California
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United States of America
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Florida
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United States of America
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Illinois
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United States of America
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Maryland
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United States of America
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North Carolina
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United States of America
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Oklahoma
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0
United States of America
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South Carolina
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0
United States of America
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Tennessee
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0
United States of America
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Texas
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Country [11]
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0
Argentina
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State/province [11]
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0
Buenos Aires
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Argentina
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State/province [12]
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Cordoba
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Argentina
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State/province [13]
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Lanus
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Argentina
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State/province [14]
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Rosario
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Argentina
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State/province [15]
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San Fernando
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Country [16]
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Argentina
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State/province [16]
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San Miguel de Tucumán
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Belgium
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Brussels
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Belgium
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State/province [18]
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Leuven
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Country [19]
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Bulgaria
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State/province [19]
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Plovdiv
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Bulgaria
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Ruse
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Bulgaria
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Sofia
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Chile
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Santiago
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Chile
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State/province [23]
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Temuco
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Country [24]
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Colombia
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State/province [24]
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Santander
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Colombia
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State/province [25]
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Barranquilla
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0
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Colombia
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State/province [26]
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Bogota
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Colombia
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State/province [27]
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Bogotá
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Colombia
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State/province [28]
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Cundinamarca
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Colombia
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Medellin
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Czechia
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Brno
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Czechia
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Kladno
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Czechia
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Praha-Nusle
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Czechia
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Zlin
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France
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Strasbourg CEDEX
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Germany
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Berlin
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Germany
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Hamburg
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Guatemala
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Guatemala City
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Guatemala
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State/province [38]
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Guatemala
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0
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Hungary
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State/province [39]
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0
Balatonfured
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Country [40]
0
0
Hungary
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State/province [40]
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0
Budapest
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0
0
Hungary
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State/province [41]
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0
Eger
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0
0
Hungary
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0
Veszprem
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0
0
Israel
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State/province [43]
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0
Haifa
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Latvia
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Adazi
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Mexico
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Mexico
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Mexico
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Mexico
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Moldova, Republic of
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Chisinau
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Galati
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Russian Federation
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Moscow
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Russian Federation
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Russian Federation
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Russian Federation
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Russian Federation
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Russian Federation
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Vladimir
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A Coruña
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Spain
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Kiev
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Kyiv
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Ukraine
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Vinnytsya
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Galapagos NV
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Gilead Sciences
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Summary
Brief summary
The primary objective of the study was to evaluate the long-term safety and tolerability of
filgotinib (formerly GLPG0634) for the treatment of rheumatoid arthritis.
Participants were enrolled in this open-label long-term follow-up study after they had
completed one of the two core studies, GLPG0634-CL-203 (DARWIN1) (NCT01888874) or
GLPG0634-CL-204 (DARWIN2) (NCT01894516), and were evaluated for any side effects that might
have occured (long-term safety and tolerability) when taking filgotinib. During the course of
the study, participants were also examined for long-term effects of filgotinib administration
on disease activity (efficacy), participant's disability, fatigue, and quality of life.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02065700
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Contacts
Principal investigator
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Galapagos Study Director
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Galapagos NV
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02065700
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